Electrical Nerve Block for Amputation Pain
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02221934 |
Recruitment Status :
Active, not recruiting
First Posted : August 21, 2014
Last Update Posted : November 22, 2022
|
Sponsor:
Neuros Medical, Inc.
Information provided by (Responsible Party):
Neuros Medical, Inc.
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | August 15, 2014 | |||
First Posted Date ICMJE | August 21, 2014 | |||
Last Update Posted Date | November 22, 2022 | |||
Actual Study Start Date ICMJE | October 9, 2014 | |||
Actual Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
|
|||
Original Primary Outcome Measures ICMJE |
|
|||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
|
|||
Original Secondary Outcome Measures ICMJE |
|
|||
Current Other Pre-specified Outcome Measures |
Exploratory Efficacy: Prosthetic Use [ Time Frame: 12 months post implant ] Average hours of prosthetic use per week averaged across two weeks compared at Month 3, Month 6 and Month 12 to Baseline.
|
|||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Electrical Nerve Block for Amputation Pain | |||
Official Title ICMJE | High-Frequency Nerve Block for Post-Amputation Pain: A Pivotal Study | |||
Brief Summary | The purpose of the clinical trial is to learn whether electrical nerve block via the Altius System is a safe and effective treatment for patients with post-amputation pain. | |||
Detailed Description | The Altius System is an implanted device designed to electrically block nerve signals and alleviate pain. Use of this device may be associated with providing an effective, mechanism-based yet non-destructive, treatment for managing intractable limb pain in amputees. In a given patient, the Altius System will be deemed effective if treatment results in 50% reduction of pain score for more than 50% of all pain episodes. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
|||
Condition ICMJE |
|
|||
Intervention ICMJE | Device: Altius
Electrical signal
|
|||
Study Arms ICMJE |
|
|||
Publications * | Soin A, Shah NS, Fang ZP. High-frequency electrical nerve block for postamputation pain: a pilot study. Neuromodulation. 2015 Apr;18(3):197-205; discussion 205-6. doi: 10.1111/ner.12266. Epub 2015 Feb 5. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
Recruitment Information | ||||
Recruitment Status ICMJE | Active, not recruiting | |||
Actual Enrollment ICMJE |
180 | |||
Original Estimated Enrollment ICMJE |
130 | |||
Estimated Study Completion Date ICMJE | December 31, 2026 | |||
Actual Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Key Inclusion Criteria:
Key Exclusion Criteria:
|
|||
Sex/Gender ICMJE |
|
|||
Ages ICMJE | 21 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02221934 | |||
Other Study ID Numbers ICMJE | 003-0001 QUEST Trial ( Other Identifier: Neuros Medical ) |
|||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Neuros Medical, Inc. | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | Neuros Medical, Inc. | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
|
|||
PRS Account | Neuros Medical, Inc. | |||
Verification Date | November 2022 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |